Guidelines

Guidelines

Patients who may be appropriate for Zypitamag™(pitavastatin)

Pitavastatin is recommended in the most recent ACC/AHA Statin Intensity Guidelines as a moderate intensity statin (2 mg and 4 mg).1

Boldface type indicates specific statins and doses that were evaluated in RCTs. All of these RCTs demonstrated a reduction in major cardiovascular events. Italic type indicates statins and doses that have been approved by the FDA but were not tested in the RCTs reviewed.

IMPORTANT SAFETY INFORMATION FOR ZYPITAMAG™ (pitavastatin)

INDICATIONS & USAGE

Drug therapy should be one component of multiple-risk-factor intervention in individuals who require modifications of their lipid profile. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol only when the response to diet and other nonpharmacological measures has been inadequate.

Limitations of Use: Doses of Zypitamag™ greater than 4 mg once daily were associated with an increased risk for severe myopathy in premarketing clinical studies. Do not exceed 4 mg once daily dosing of Zypitamag™. The effect of Zypitamag™ on cardiovascular morbidity and mortality has not been determined. Zypitamag™ has not been studied in Fredrickson Type I, III, and V dyslipidemias.

CONTRAINDICATIONS

Zypitamag™ is contraindicated in patients with a known hypersensitivity to product components, in patients with active liver disease (which may include unexplained persistent elevations in hepatic transaminase levels), in women who are pregnant or may become pregnant, in nursing mothers or in coadministration with cyclosporine.

WARNINGS & PRECAUTIONS

Skeletal Muscle Effects: Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with HMG-CoA reductase inhibitors, including pitavastatin.

These risks can occur at any dose level, but increase in a dose-dependent manner, with advanced age (≥ 65 years), renal impairment, and inadequately treated hypothyroidism; administer with caution in these patients, or when used concomitantly with fibrates or lipid-modifying doses of niacin, or colchicine. Avoid concomitant administration with gemfibrozil.

Zypitamag™ should be discontinued if markedly elevated creatine kinase levels occur or myopathy is diagnosed or suspected.

Zypitamag™ should also be temporarily withheld in any patient with an acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (e.g., sepsis, hypotension, dehydration, major surgery, trauma, severe metabolic, endocrine, and electrolyte disorders, or uncontrolled seizures).

Fatal and non-fatal hepatic failure can occur. Interrupt Zypitamag™ if serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs. If an alternate etiology is not found do not restart Zypitamag™.

Use Zypitamag™ with caution in patients who consume substantial quantities of alcohol and/or have a history of chronic liver disease. Do not use Zypitamag™ if patient has active liver disease, which may include unexplained persistent transaminase elevations.

Endocrine Function:

Increases in HbA1c and fasting serum glucose levels have been reported.

COMMON ADVERSE REACTIONS

Myalgia, back pain, diarrhea, constipation and pain in extremity (rate ≥ 2% in at least one marketed dose). This is not a complete list of all reported adverse events.